Canada License Amendment - Old Product to New Product



I am hoping someone can provide me with some assistance as I have tried to find the answer myself and come up empty handed.

We currently have a few medical device licenses in Canada and wish to amend one of them to add a new product that is essentially replacing the existing product. There is no significant change from the old product to the new product, same intended use, same everything except it looks a little different. I am getting ready to submit the amendment application and I was wondering what, if any, is the time period from submission of the amendment and our ability to actually sell the product to our distributor.

Can we sell immediately after we submit the amendment or do we need to wait for some sort of approval or acknowledgment from Canada?

Edward Reesor

Trusted Information Resource
Since the addition to the license is a fax back form, the process should only take a few days. The certificates are issued electronically as well, so the total time is surprisingly fast.

Keep in mind that the actual license number may change, as amended licenses result in a new MDL number for the original device.
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